If you have any complaints regarding products regulated by the U.S. Food and Drug Administration (FDA), the agency encourages you to share your experiences. The FDA provides several methods for reporting issues, with two primary channels being Consumer Complaint Reporting System and MedWatch.
Consumer Complaint Reporting
In line with its efforts to modernize field operations, all FDA Centers now directly receive reports about problems or adverse reactions associated with FDA-regulated products. To report your concerns, you can visit the SmartHub webpage on the FDA website, which will guide you to the appropriate webform or phone number based on your issue. Alternatively, if you prefer not to use the SmartHub, you may call 1-888-INFO-FDA and follow the prompts for reporting a problem. If you require assistance using relay services due to accessibility needs, please contact the Federal Relay Services at 800-877-8339; this is a toll-free service that facilitates calls between federal agencies from TTY devices.
Please note that previous ORA consumer complaint coordinator telephone numbers are no longer active. Some examples of complaints that the FDA values include food-related illnesses, especially when specific foods or ingredients suspected to cause allergic reactions are involved. The agency also takes interest in issues related to infant formula and baby food, as well as problems with canned goods, tampering cases, adverse events from dietary supplements, prescription medications (both over-the-counter and prescription), pet food and treats.
Reporting these issues can lead the FDA to take action. Serious complaints might result in an investigator visiting the complainant’s location or collecting product samples for further analysis. The agency may also initiate inspections based on such reports. For less serious matters that appear isolated, information is collected for future reference during company inspections and discussed with management.
MedWatch Reporting
MedWatch gathers public reports and publishes safety alerts related to FDA-regulated products like prescription drugs, over-the-counter medications, biologics (including blood components), medical devices (such as hearing aids or pacemakers), combination products (like pre-filled drug syringes), special nutritional products (medicinal foods and infant formulas), cosmetics, food items (excluding dietary supplements). Products under other FDA regulations such as tobacco products, vaccines, animal drugs and devices, pet food and livestock feed use different reporting systems. For these cases, direct submission to the appropriate portals is recommended.
Dietary supplement adverse events should be reported through the Safety Reporting Portal. After receiving a report on MedWatch or via other means like contacting your healthcare provider (CCC), FDA staff enters it into their database for review and comparison with similar reports.
Safety Reporting Portal
The Safety Reporting Portal serves as another essential reporting tool, especially for problems involving tobacco products, human dietary supplements, pet food/treats, or livestock food—all regulated by the FDA. This portal also includes a routing page that guides users to appropriate federal resources if they’re unsure where their issue should be reported.
